FDA.reportPublic FDA data

Cellfina Prep Pack

Primary DI
00840763100377
Brand
Cellfina Prep Pack
Company
Ulthera, Inc.
Model
CP1 Rev D
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUPPowered Surgical Instrument For Improvement In The Appearance Of CelluliteGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153677000The Cellfina SystemUlthera, Inc.2016-02-25OUP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840763100377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840763100377008407631003778407631003770840763100377

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical skin contouring system injection/transection setA collection of sterile components of a mechanical skin contouring system intended to temporarily minimize the manifestation of cellulite by transection of the cellulite-tethering fibrous tissue by motorized mechanical means. It consists of template plates, needle and microblade assemblies to guide instruments, and a vacuum-assisted capture unit to control the tissue being treated. The device is placed on the skin, an area of skin/subcutaneous tissue is drawn by suction into a dome, and local anaesthesia is infiltrated prior to subcutaneous transection by a motorized cutting tool. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010981554
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840763100001Ulthera System Control UnitUC-1 Rev. A2016-09-07
00840763100018Ulthera System HandpieceUH-2 Rev. A2017-05-23
00840763100155Ulthera System Control UnitUC-1 Rev. B2016-09-07
00840763100162Ulthera System Control UnitUC-1 Rev. C2016-09-07
00840763100179Ulthera System Control UnitUC-1 Rev. D2016-09-07
00840763100186Ulthera System Control UnitUC-1 Rev. E2016-09-07
00840763100193Ulthera System Control UnitUC-1 Rev. F2016-09-07
00840763100209Ulthera System Control UnitUC-1 Rev. G2016-09-07
00840763100216Ulthera System Control UnitUC-1 Rev. H2016-09-07
00840763100223Ulthera System Control UnitUC-1 Rev. I2016-09-07
00840763100230Ulthera System Control UnitUC-1 Rev. J2016-09-07
00840763100247Ulthera System Control UnitUC-1 Rev. K2016-09-07
00840763100254Ulthera System Control UnitUC-1 Rev. L2016-09-07
00840763100261Ulthera System HandpieceUH-2 Rev. B2017-05-23
00840763100278Ulthera System HandpieceUH-2 Rev. C2016-09-06
00840763100285Ulthera System HandpieceUH-2 Rev. D2016-09-06
00840763100292Ulthera System HandpieceUH-2 Rev. E2016-09-06
00840763100308Ulthera System HandpieceUH-2 Rev. F2016-12-14
00840763100421Ulthera System HandpieceUH-2 Rev. G2016-12-14
00840763100438Ulthera System HandpieceUH-2 Rev. H2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850036790013AveliRevelle Aesthetics, Inc.OUP2024-02-26
00850036790006AveliRevelle Aesthetics, Inc.OUP2022-02-14
00840763100742Cellfina Motor Module Device and PackageUlthera, Inc.OUP2020-01-24
00840763100414Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100520Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100612Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100766Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100803Cellfina Prep PackUlthera, Inc.OUP2019-07-18
00840763100827Cellfina System Disposable Procedure KitUlthera, Inc.OUP2019-03-18
00840763101015Cellfina System CartUlthera, Inc.OUP2019-03-08
00840763100537CellfinaUlthera, Inc.OUP2016-12-14
00840763100544Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-12-14
10840763100107Cellfina System Procedure Kit (Single Package)Ulthera, Inc.OUP2016-12-12
00840763100087Cellfina Prep Pack for EUUlthera, Inc.OUP2016-12-12
00840763100094Cellfina System Disposable TrayUlthera, Inc.OUP2016-09-07
00840763100117Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-09-07
00840763100124Cellfina Prep PackUlthera, Inc.OUP2016-09-07
00840763100384Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-09-07
00840763100391Cellfina System Disposable TrayUlthera, Inc.OUP2016-09-07
00840763100407Cellfina System Disposable TrayUlthera, Inc.OUP2016-09-07
00840763100568Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-09-07